SINUS RELIEF DAY AND NIGHT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCO ASSOCIATES LLC]

SINUS RELIEF DAY AND NIGHT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCO ASSOCIATES LLC]
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NDC 36800-569-01
Set ID 55762d52-a35b-4087-b133-a9f446f64f7f
Category HUMAN OTC DRUG LABEL
Packager TopCo Associates LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each Sinus Day caplet)Purpose
    Acetaminophen 325 mgPain reliever
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant

    Active ingredients (in each Sinus Night caplet)Purpose
    Acetaminophen 325 mgPain reliever
    Diphenhydramine HCl 25 mgAntihistamine
    Phenylephrine HCl 5 mgNasal decongestant

  • Uses

    • temporarily relieves:
      • nasal congestion
      • headache
      • minor aches and pains
      • sinus congestion and pressure
      • runny nose and sneezing (SINUS NIGHT ONLY)
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (SINUS DAY ONLY)
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 12 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert

    acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product containing diphenhydramine, even one used on skin (SINUS NIGHT ONLY)
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • glaucoma (SINUS NIGHT ONLY)
    • a breathing problem such as emphysema or chronic bronchitis (SINUS NIGHT ONLY)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS DAY ONLY)
    • cough that occurs with too much phlegm (mucus) (SINUS DAY ONLY)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (SINUS NIGHT ONLY)

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children (SINUS NIGHT ONLY)
    • marked drowsiness may occur (SINUS NIGHT ONLY)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS NIGHT ONLY)
    • avoid alcoholic drinks (SINUS NIGHT ONLY)
    • be careful when driving a motor vehicle or operating machinery (SINUS NIGHT ONLY)

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or persistent headache

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed (see Overdose warning)
    • do not take Sinus Day and Sinus Night caplets at the same time
    • do not take more than 12 caplets in any 24-hour period
    • adults and children 12 years and older: take 2 caplets every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store between 20-25°C (68-77°F) in a dry place
    • retain carton for complete product information
  • Inactive ingredients

    SINUS DAY

    colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

    SINUS NIGHT

    colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

  • PRINCIPAL DISPLAY PANEL

    NDC 36800-569-01

    TopCare® Health

    For Ages 12+

    Compare to Mucinex® Sinus-Max™ Day & Night Active Ingredients*

    Maximum Strength†

    Sinus Relief Day & Night

    Daytime

    Pain Reliever – Acetaminophen

    Expectorant – Guaifenesin

    Nasal Decongestant – Phenylephrine HCl

    Day Caplet Relieves:

    Sinus Pressure

    Headache & Congestion

    Thins & Loosens Mucus

    Nighttime

    Pain Reliever – Acetaminophen

    Antihistamine – Diphenhydramine HCl

    Nasal Decongestant – Phenylephrine HCl

    Night Caplet Relieves:

    Nasal Congestion

    Sinus Pressure & Pain

    Runny Nose & Sneezing

    Our Pharmacists Recommend

    10 Day Caplets

    10 Night Caplets

    image description

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF DAY AND NIGHT 
    acetaminophen, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-569
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-569-011 in 1 CARTON; Type 0: Not a Combination Product06/30/201708/31/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 10 
    Part 21 BLISTER PACK 10 
    Part 1 of 2
    ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code AAA;1166
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Part 2 of 2
    ACETAMINOPHEN, DIPHENHYDRAMINE HYROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE (UNII: D9C330MD8B)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorImprint Code AAA;1116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/201708/31/2023
    Labeler - TopCo Associates LLC (006935977)

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